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The PORTAGE System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the PORTAGE Endoscope and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants. Other examples of generic surgical use of the PORTAGE System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

The PORTAGE System is comprised of an endoscope and manual athroscopic instruments.

The PORTAGE Endoscope is a reusable rigid endoscope, comprised of a fiber optic cable and sensitive image transmission system with eyepiece. The PORTAGE Endoscope is used for visualization of the surgical field during arthroscopic or spinal procedures and may be used in conjunction with a separately cleared and commercially available light quide, light source, video camera, monitor and printer. Light that is created by the external light source is transmitted from the PORTAGE Endoscope light quide connector through the endoscope itself to the tip via a fiber optic system. Images are transferred the other way back through a rigid rod lens system. The subject endoscope is manufactured in a 90° short confiquration and is used with a compatible bracket. The PORTAGE Endoscope is supplied non-sterile.

The PORTAGE System accessories are manual instruments that include retractors, dilators, rongeurs, forceps, suture passers, cutters, pushers, probes, curettes and gouges. They enable the physician to perform any type of surgical spinal procedure. The manual instruments are either single-use and supplied sterile, or reusable and supplied non-sterile.

The reusable PORTAGE System components have undergone complete reprocessing validations, including manual cleaning and steam sterilization.

This document is a 510(k) Summary for the PORTAGE™ System, an arthroscope, seeking FDA clearance. It describes the device's substantial equivalence to a predicate device (METRx System, K002931) rather than presenting a performance study against specific acceptance criteria for an AI/ML powered device.

Therefore, the provided text does NOT contain the information needed to answer the questions about acceptance criteria and a study proving a device meets those criteria for an AI/ML system.

The "Performance Testing" section states: "Performance testing has been completed for the PORTAGE System to demonstrate substantial equivalence to the predicate METRx System (K002931). As applicable, the system components have been subjected to the following verification and validation testing: general performance including endoscope field and direction of view, diopters, eccentricity, size of view, and vignetting, biocompatibility, system compatibility and usability. All test requirements were met as specified by applicable standards and the test protocols."

This indicates that general device performance (optical properties, usability, biocompatibility) was tested to show it functions similarly to the predicate, it is not an AI/ML powered device, thus there is no AI/ML related performance to discuss.

Based on the provided text, I cannot answer the questions about acceptance criteria and a study for an AI/ML device. The document describes a traditional medical device (an arthroscope) and its 510(k) clearance process, which focuses on substantial equivalence to a predicate device, not on AI/ML performance metrics.

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The InnerVue™ Diagnostic Scope System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. Examples of generic surgical use include the visualization of joints within the body. These joints can include, joints located in the torso/trunk, upper/lower extremities, and the temporomandibular joint.

The InnerVue™ Diagnostic Scope System consists of five (5) main parts: hardware, software, instrumentation and procedural kit(s).

Hardware: The hardware consists of the following components: Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece (which incorporates the camera head and light cable), a slide-out working surface and a storage drawer.

Software: The software enhances the image from the scope to remove fiber optic pixilation without adding distortion. The software allows the operator to record and print still images as well as record and archive audio and video information recorded during the procedure.

Scope: A rigid fiber optic scope designed for one-time use.

Supplementary Instruments: Supplementary instruments consist of four (4) pieces that can be used interchangeably throughout the procedure. The four components are a cannula, a trocar, and a cannula plug. Both disposable supplementary instruments are available with the system.

Procedural Kits: Supplementary items to assist in the surgical procedure.

The provided text states, "Clinical Testing: None provided as a basis for substantial equivalence." This means that no clinical study was conducted to prove the device meets acceptance criteria specific to its diagnostic or operational performance related to medical outcomes.

Instead, the device's substantial equivalence and performance are based on compliance with electrical safety and general medical equipment standards.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical testing with a test set was conducted for substantial equivalence. The performance assessment was based on compliance with electrical and safety standards, not clinical data or patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical testing was performed, so no experts were used to establish ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical testing was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC study was mentioned or conducted, as the device is not an AI-assisted diagnostic tool and no clinical testing was performed for substantial equivalence.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. No standalone algorithm performance was assessed as this is a medical device for visualization and illumination, not an AI or algorithm-based diagnostic tool. The performance was assessed against safety and electrical standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. Ground truth in a clinical sense was not established as no clinical testing was performed. The "ground truth" for compliance was the requirements outlined in the specified electrical and medical device safety standards.

8. The sample size for the training set

Not applicable. No training set was used as this device does not involve machine learning or AI that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

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The MAST QUADRANT™ Retractor System is intended to provide surgeons with instruments such as dilators, retractors, light sources and pedicle access needles used to perform a variety of spinal fixation procedures utilizing a minimally invasive approach.

The MAST QUADRANT™ Retractor System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the MAST QUADRANT™ Retractors and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants.

The MAST QUADRANT™ Retractor System is a tubular-based retraction system, designed to provide surgeons with the freedom to retract tissue through any combination of distracting or articulating the blades. The MAST QUADRANT™ System includes instruments used to access the spine by dilating the overlying tissues, as well serving as a retracting device to maintain the access. The system can be used in conjunction with microscopes, light sources, cameras, or other visualization aids.

This document is a 510(k) summary for the MAST QUADRANT™ Retractor System. It describes the device and its intended use, and states that substantial equivalence was demonstrated to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on demonstrating substantial equivalence to existing devices rather than presenting performance data against specific acceptance criteria.

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